Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT01032109
First received: December 12, 2009
Last updated: December 14, 2009
Last verified: May 2008
  Purpose

The purpose of this study is to compare 12-month results of two single initial treatments—photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab—for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.


Condition Intervention
Age-Related Macular Degeneration
Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: The comparison between baseline and 12-month ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab Drug: Bevacizumab
A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • choroidal neovascularization caused by age-related macula degeneration
  • no previous treatment
  • a follow-up at least 12 months
  • a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

  • choroidal neovascularization caused by other eye diseases
  • ocular surgery within the past 3 mouths
  • history of uveitis
  • intraocular pressure higher than 25 mmHg, or glaucoma
  • history of systemic or ocular thromboembolic events.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032109

Locations
Japan
Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University
1-1-1 Honjo, Kumamoto, Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
Principal Investigator: Takahiro Kawaji, MD, PhD Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
  More Information

No publications provided by Kumamoto University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takahiro Kawaji, Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
ClinicalTrials.gov Identifier: NCT01032109     History of Changes
Other Study ID Numbers: PCBK610
Study First Received: December 12, 2009
Last Updated: December 14, 2009
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014